No Regional Differences in Quality of Clinical Trial Data

Acrohealth.org: July 12, 2012 – WASHINGTON, DC – “A formal statistical evaluation indicates no significant differences in data quality for clinical trials conducted in developing regions relative to mature regions,” says an article published in the July 2012 issue of the Drug Information Journal. The article by Pankaj B. Desai, PhD, of the Drug Development Graduate Program, College of Pharmacy at the University of Cincinnati, analyzed 26 large-scale multi-regional Phase II/III clinical trials enrolling nearly 64,000 participants at more than 4,700 research sites.

Members of the Association of Clinical Research Organizations contributed data covering 10 regions and multiple therapeutic areas. The study compared query rates and database changes, which are accepted measures for assessing clinical trial data quality. The study’s overall data set included 1.39 million queries on 7.5 million pages of case report forms on over 95 million data parameters. ACRO provided funding for the project. Read more